Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients

NCT05709522 | Unknown

• 1 other identifier: 2021-4859-18168.
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This will be the first in-depth study to evaluate pretreatment and 12 months post-treatment, neurocognitive and psychological outcomes of children with brain tumor and blood cancer in Pakistan. The investigators will also determine the socioeconomic burden of pediatric brain tumors in low middle-income region and the association of micro RNA and protein markers with neurocognitive outcomes in PBT and blood cancer children. A prospective cohort study with a follow-up of 12 months at the Aga Khan University Hospital, Karachi, Pakistan and Jinnah postgraduate Medical Centre , Karachi, Pakistan will be conducted. After taking consent/ assent the investigators will recruit 80, 5-21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment. Trained psychologist will assess the neurocognitive outcomes by the Slosson scale, Raven's progressive matrices and Wechsler Intelligence Scale for children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV) tools. The Quality of life and depression of the children will be determined by PedQL and Revised Children's Anxiety and Depression Scale (RCADS) and hospital anxiety and depression scale (HADs) respectively . The financial burden of the disease on the family will be measured on a visual analog scale ranging from no burden (0) to very large burden (100) and the parents QoL and disrupted schedule, financial problems, lack of family support, health problems and the impact of caregiving on caregiver's self-esteem will be assessed by Pediatric Quality of Life Inventory PedQl (family module) and Caregiver Reaction Assessment (CRA) tools respectively. The serum micro RNA (mi-21, mi-10b and mi-210) and protein markers (GFAP, NSE and S100β) will be assessed by qRT-PCR and ELISA.

Conditions

Brain Tumor, Pediatric; Blood Cancer

Keywords

Pediatric Brain tumor; Blood Cancer; Neurocognition; Psychosocial outcomes; Quality of life; depression; socioeconomic burden

Outcome Measures

Primary Outcomes (5)

• Neuro-cognitive outcomes

  The Verbal component of neurocognition will be assessed by slosson scale.A higher score means a better outcome

  November 2020 to November 2023

• Neuro-cognitive outcomes

  The non verbal component of neurocognition will be assessed by Raven tool (non verbal) a higher score means good neurocognition

  November 2020 to November 2023

• Neuro-cognitive outcomes

  The non verbal component i.,e processing speed of neurocognition will be assessed by Wechler scale . A high score means good neurocognition

  November 2020 to November 2023

• Quality of life of child

  Pediatric Quality of Life Inventory tools ( generic, brain module and cancer module); Score 0-100; higher scores means good Quality of life

  November 2020 to November 2023

• Depression and anxiety

  Revised Children's Anxiety and Depression Scale and hospital anxiety and depression scale; score 0-141 a higher score mean high depression and anxiety; 0-7 mild depression and anxiety; 8=10 moderate depression and anxiety and 11-21 severe depression and anxiety

  November 2020 to November 2023

Secondary Outcomes (7)

• Parents health related Quality of life

  November 2020 to November 2023

• MicroRNA

  November 2020 to November 2023

• S100 calcium-binding protein B (S100β)

  November 2020 to November 2023

• Neurons and peripheral neuroendocrine cells (NSE)

  November 2020 to November 2023

• Glial fibrillary acidic protein (GFAP)

  November 2020 to November 2023

Study Arms (2)

Pediatric brain tumor patients

The study participants will be 5 to 21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment

Behavioral: Neurocognitive tools

Blood cancer children

The study participants will be 5 to 21 years old children with newly diagnosed blood cancer presenting with any stage, who have not undergone any treatment

Behavioral: Neurocognitive tools

Interventions

Neurocognitive tools BEHAVIORAL

Neurocognitve and psychological tools

Also known as: Psychosocial tools

Blood cancer children; Pediatric brain tumor patients

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

5-21 years old pediatric brain tumor and blood cancer patients

You may qualify if:

• years children with brain tumor, presenting with any stage
• Children residing in Pakistan for at least 3 months.
• Children accompanied by both or either of the parent
• Children with basic understanding of English
• Children and their parents who understand and speak in Urdu
• Children and their parents who will give assent / consent to participate in the study

You may not qualify if:

• Children who have received any type of treatment for brain tumor and blood cancer
• Children presenting with recurrence
• Children with metastatic brain tumor and blood cancer
• Known cases of any illness leading to psychiatric/neurological illness (e.g. ADHD, autism, schizophrenia) as confirmed by medical records, will be excluded from the study as they may be on medications that might distort the results.
• Children with physical comorbidities and debilitating disease
• Children who will loss to follow-up

Sponsors & Collaborators

• Aga Khan University: lead
• Jinnah Postgraduate Medical Centre: collaborator

Study Sites (1)

Nida Zahid

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (1)

• Zahid N, Enam SA, Martensson T, Azam I, Mushtaq N, Moochhala M, Javed F, Kausar F, Hasan A, Rehman L, Mughal MN, Altaf S, Kirmani S, Brown N. Predictors of neurocognition outcomes in children and young people with primary brain tumor presenting to tertiary care hospitals of Karachi, Pakistan: a prospective cohort study. Childs Nerv Syst. 2024 Jun;40(6):1707-1719. doi: 10.1007/s00381-024-06306-x. Epub 2024 Feb 16.

  PMID: 38363314 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be stored to assess microRNA and Protein markers

MeSH Terms

Conditions

Brain Neoplasms; Hematologic Neoplasms; Depression

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: February 2, 2023
• Study Start: November 20, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)